The Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures; A U.S. Prospective Case Series
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ASES Score- 1 year
研究概览
简要总结
The goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the Section 510(K) approved Anser Clavicle Pin in a prospective 50 patient clinical trial in a U.S. population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
- •Skeletally mature
- •Surgery performed within 4 weeks after trauma
排除标准
- •Not fit for surgery by the anesthesiologist
- •Nonunion or previous malunion
- •Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
- •Additional neurovascular injury
- •Pathologic fractures
研究组 & 干预措施
Anser Clavicle Pin
Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture
干预措施: Anser Clavicle Pin (Device)
结局指标
主要结局
ASES Score- 1 year
时间窗: 1 year post-operation
American Shoulder and Elbow Surgeons Score
DASH Score- 6 week
时间窗: 6 weeks post-operation
Disabilities of Arm, Shoulder and Hand Score
ASES Score- 2 week
时间窗: 2 weeks post-operation
American Shoulder and Elbow Surgeons Score
Radiographic union rate
时间窗: 1 year post-operation
Radiographic union is defined as a 2/3rd circumferential cortical bridging between medial and lateral fragments on both radiographs as determined by the treating surgeon and an independent radiologist
ASES Score- 3 month
时间窗: 3 months post-operation
American Shoulder and Elbow Surgeons Score
ASES Score- 6 week
时间窗: 6 weeks post-operation
American Shoulder and Elbow Surgeons Score
DASH Score- 2 week
时间窗: 2 weeks post-operation
Disabilities of Arm, Shoulder and Hand Score
DASH Score- 1 year
时间窗: 1 year post-operation
Disabilities of Arm, Shoulder and Hand Score
DASH Score- 3 month
时间窗: 3 months post-operation
Disabilities of Arm, Shoulder and Hand Score
Clinical union rate
时间窗: 1 year post-operation
Clinical union is defined as the absence of pain over the fracture site upon palpation.
次要结局
未报告次要终点